Summary

The purpose of this study is to determine when a memory immune response after re-vaccination
with Meningococcal C conjugate vaccine (Menjugate) or challenge with Meningococcal A/C
polysaccharide vaccine can be observed, after initial vaccination with Meningococcal C
conjugate vaccine during the UK immunization campaign

Study Design

Allocation

randomized

Endpoint classification

safety/efficacy study

Intervention model

parallel assignment

Masking

open label

Primary purpose

prevention

Primary Outcomes

Measure

To measure immunological memory response to N. meningitidis serogroup C after those who received a partial dose of Meningococcal A/C Polysaccharide vaccine and in subjects who received a dose of Chiron Meningococcal C conjugate vaccine.

time frame:

Secondary Outcomes

Measure

To assess the immunological response to N. meningitidis serogroup C in those challenged with meningococcal A/C polysaccharide vaccine and in those who received a dose of Chiron Meningococcal C conjugate vaccine.

time frame:

Eligibility Criteria

Male or female participants from 13 years up to 15 years old.

Inclusion Criteria:
- Healthy adolescents between and including 13-15 years of age, who provide written
informed consent and who received one immunization with Chiron Meningococcal C
Conjugate vaccine (Menjugate) during the UK immunization campaign and for which
documentation can be provided.
Exclusion Criteria:
- Subjects with a previous or suspected disease caused by N. meningitidis; or previous
immunization with a meningococcal vaccine or vaccine containing meningococcal
antigen(s); Any serious acute, chronic or progressive disease

Additional Information

Official title

A Phase IV, Single Center, Open-Label, Controlled, Randomized Study to Evaluate the Memory Response of Children Previously Vaccinated With Chiron Meningococcal C Conjugate Vaccine, Menjugate® and Describe the Kinetic of the Antibody Response and Maturation on Days 2-7 and 28 After Challenge With Pasteur Merieux Meningococcal A/C Polysaccharide Vaccine or Menjugate®

Principal investigator

Andrew J. Pollard, MBBS, FRCPCH, PhD

Trial information was received from ClinicalTrials.gov and was last updated in December 2005.